Heart Rate Regularization in Atrial Fibrilation and Heart Failure

Recruiting now · Not applicable

Conditions studied: Heart Failure, Atrial Fibrillation

In brief

The PACE-FIB trial is a multicentre, randomised, open-label clinical trial. Patients older than 18 years, with permanent AF, LVEF\>40%, average resting heart rate ≤ 110 beats per minute (bpm), at least one hospitalisation due to HF in the previous year and basal NT-proBNP level\>900 pg/ml will be randomised to either CSP and subsequent AV node ablation (intervention group) vs. pharmacologic rate control optimised according to clinical practice guidelines. The impact of both strategies on a composite primary endpoint of all-cause mortality, HF hospitalisation and worsening HF will be evaluated during a 36-month follow-up.

Key facts

Study ID

NCT05029570

Run by

Daniel Rodríguez Muñoz

People needed

334

Starts

2022-04-29

Expected to finish

2030-09-01

Last updated by the study team

2025-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Permanent atrial fibrillation
• At least one episode of hospitalisation due to heart failure in the previous 12 months.
• Left ventricular ejection fraction > 40%
• Average resting heart rate ≤ 110 beats per minute
• NT-proBNP ≥ 900 pg/ml in the 30 days prior to enrollment
• Age ≥ 18 years
• Capacity to understand the nature of the study, legal ability and willingness to give informed consent.

You may not qualify if…

• Severe frailty (Clinical Frailty Scale ≥ 7) or comorbidity reducing life expectancy to < 12 months.
• Acute heart failure at the time of enrollment or systolic blood pressure < 80 mmHg in the absence of inotropic agents.
• Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 20 ml/1,73 m2
• Severe mitral or aortic valvular heart disease
• Anaemia (Haemoglobin < 10 g/dl)
• Morbid obesity (BMI ≥ 35)
• Severe Chronic Obstructive Pulmonary Disease (Gold ≥ 3)
• Presence of a different indication for pacing of implantable cardioverter-defibrillator (ICD)
• Obstructive hypertrophic cardiomyopathy
• Infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others)
• Simultaneous participation in a different trial

Where it is running

• Hospital Universitario 12 de Octubre — Madrid, Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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